2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 12, 1997 through March 20, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): CF-C-1607
- Physical state: yellow solid
- Analytical purity: >98%
- Lot/batch No.: 003
- Expiration date of the lot/batch: August 31, 1998
- Storage condition of test material: at room temperature (ca. 20°C) away from direct sunlight

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, D-88397 Biberach/Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: Male: 2900 g; Females: 2823 - 2983 g
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no. 75/97).
- Water (e.g. ad libitum): Community tap water· from Itingen, ad libitum, in water bowls
- Acclimation period: Four days under test conditions after health examination. Only animals without any visual signs of illness wree used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

Moisted with bi-distilled water

Controls:

no

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g per animal

Duration of treatment / exposure:

4 hours

Observation period:

72 hours following treatment

Number of animals:

1 male, 2 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 of the intact skin of the clipped area
- Type of wrap if used: A 2.5 cm x 2.5 cm patch of surgical gauze covered with a semi-occlusive dressing. The dressing was wrapped around theabdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to EEC Commission Directive 92/691EEC, July 31, 1992

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

Reversible light yellow staining by the test article of the treated skin was observed.

Any other information on results incl. tables

Table 1. Body weight (g) of test animals.

Animal No.	Sex	First Day of Acclimatisation	First Day of Treatment	Last Day of Treatment
16	Male	2900	2971	2999
17	Female	2983	3150	3351
18	Female	2823	2966	3041

Table 2. Skin irritation scores - individual values.

Animal No.	Sex	Evaluation Interval	Erythema	Edema	Cumulative
					Score	Mean
16	M	1 hour	0	0	0.00	0.00
17	F		0	0	0.00
18	F		0	0	0.00
16	M	24 hours	0	0	0.00	0.00
17	F		0	0	0.00
18	F		0	0	0.00
16	M	48 hours	0	0	0.00	0.00
17	F		0	0	0.00
18	F		0	0	0.00
16	M	72 hours	0	0	0.00	0.00
17	F		0	0	0.00
18	F		0	0	0.00

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

Based on these observations and on the referred classification criteria, CGP-C-1607 is considered to be "not irritating" to rabbit skin.

Executive summary:

The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 cm2 intact dorsal skin of each of three young adult New Zealand rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures. The primary irritation score was 0.00 (max. 8.0). Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. The test article caused reversible light yellow staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based upon the referred classification criteria, the test article is considered to be "not irritating" to rabbit skin.